From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP. EU GMP does require you to have a QA system, but there is no mention of who should manage the system. In a number of courses that I have presented in the past we have looked at what the delegates think QA’s role should be, bearing in mind the role is not defined in GMP. Roles already assigned in GMP to the Head of QC and the QP can be delegated to QA, with additional roles added as well. Their findings are below:

The QA Manager (suggested duties from course delegates)

Control of Licences

Liaison with Research & Development/ New Product Introduction

Batch Review

Batch Release

Management of the Document Management system

Management of the Internal Audit system

Management of the GMP Training System

Customer feedback and satisfaction

Management of deviations, incidents and investigations

Management of the Validation system

Vendor assurance and supplier auditing

Control of sub-contractors

Performance monitoring and review

Management Review

Management of the Continual Improvement system

Gathering and Trending of quality related data

Data storage

Management of the Product Quality review process

Management of the Risk Management process

Management of the Corrective Action system

Management of the Preventative Action system

These are roles commonly performed by QA departments. They are opinions from former GMP training course delegates and should not be seen as a specific GMP requirement. Please let us know what you think. Are these similar to your own QA department?